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Elizabeth Orr

Washington, DC
Elizabeth Orr focuses on legal affairs affecting the medical device industry. Before joining Informa in September 2015, she spent three years spent reporting on all things device-related at FDANews. She remains fascinated by the ever-changing master class on technology, government regulations, advances in health care and more that is covering the device industry. Elizabeth’s past employers include DecisionHealth (formerly UCG); the Society of Interventional Radiology; and the Washington Examiner.  A graduate of the College of Journalism at the University of Maryland College Park, she lives in Arlington, Va., with her husband and children.
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Latest From Elizabeth Orr

Device Week, 11 October 2019 – Total Recall: The Latest On Corrections & Removals

On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.

Device Week Recalls

New Guidewire 510(k) Guidance From FDA Advises On Coating Tests

Newly finalized guidance from the US agency updates its recommendations for 510(k) submissions for guidewires intended for use in coronary vasculature, peripheral vasculature and neurovasculature. The document, which replaces a 1995 guidance, reflects serious risks posed by certain guidewire coatings.

Review Pathway Guidance Documents

Compliance Corner: FDA Officials Share Tips To Ensure A Smooth Recall

Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.

Compliance Corner Recalls

J&J Awaits Verdict In California Pelvic Mesh Trial

An $800m lawsuit filed by the state of California against Johnson & Johnson for alleged fraudulent marketing of pelvic mesh products is in the hands of a state judge after the conclusion of a 10-week trial. This is the first lawsuit brought by a state against a pelvic mesh manufacturer to go to trial.

Gynecology & Urology Legal Issues

FTC Warns On Misleading TV Ads By Personal Injury Lawyers

Legal service ads that attempt to recruit patient plaintiffs for product-safety lawsuits against drug and device companies by resembling official medical alerts or recall notices may be deceptive or unfair, the US Federal Trade Commission warned in a recent set of letters.

Advertising, Marketing & Sales Enforcement

Q&A: Former FDA Coronary Device Officer Hops To Gore

Former US FDA cardiac device medical officer John Laschinger spoke to Medtech Insight about his work at the agency and his move to device-maker W.L. Gore & Associates as cardiac chief medical advisor.

Cardiology Commercial
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